FAQs. |More information on systems, tests and service

General

Magnet Group Signaling (MGS®) is the core of the AXINON® System. MGS® enables AXINON® to reproducibly elucidate metabolite constellations from a NMR (nuclear magnetic resonance spectroscopy) spectrum and thus allows a new dimension of NMR use for diagnostic purpose.

Nuclear magnetic resonance (NMR), is a physical phenomenon which occurs when an atomic nucleus is placed in a very strong magnetic field. The resulting signal is defined by the type and number of surrounding nuclei as well as from the electron shell. NMR is utilized in medicine and several scientific and technical fields of application.

NMR spectroscopy is widely used in, but not limited to, the field of biomedical research. On the one hand it is used to elucidate the structure and dynamics of nucleic acids, amino acids, peptides and proteins as well as to decipher their interaction with active ingredients. Structure elucidation by NMR can be done directly in solution - in contrast to X-ray structural analysis.

High-resolution NMR spectroscopy is also a key technology in the field of metabolomics/metabonomics research. The metabonomics approach uses the entirety of metabolites to draw conclusions about physiological or pathophysiological metabolic states.

Many complex questions in various biological systems can be answered using this approach. To date, metabolomics has mainly been used in research. In the future this powerful methodology and therefore NMR spectroscopy is bound to find wider application, particularly in laboratory diagnostics.

In the field of laboratory diagnostics, NMR techniques are being used increasingly successfully to determine the concentrations of metabolic products (metabolites) in body fluids such as plasma, serum or urine.

<i>AXINON<sup>®</sup></i> System</i>

AXINON® is a modular system that supports different tests for in vitro diagnostic (IVD) or research use.

The AXINON® Software supports the measurement of samples prepared using AXINON® reagents on a qualified NMR spectrometer. In conjunction with integrated test-specific software modules for in vitro diagnostic (IVD) or research use provided by numares HEALTH, the AXINON® Software enables the simple and parallel quantification of a variety of analytes which can support the diagnosis, prevention, monitoring or treatment of disease.

Currently the tests AXINON®lipoFIT®-S100 for the determination of lipoprotein subclasses in serum and AXINON® renalTX-SCORE®-U100 for renal allograft rejection diagnostics in urine are available. Numerous other tests are in development.

Yes, AXINON® is a platform solution that has been specially designed to simultaneously support different numares tests. As long as all test share the same requirements multiple tests can be executed on one sample. As long as a new test has the same or less requirements for the acquired data it is possible to reprocess already acquired data with a new numares test. For details contact the numares’ sales team.

With manual pipetting, sample preparation takes about 45 minutes for about 100 serum samples. Preparation of Urine Samples may take longer as an additional centrifugation step is necessary. Thanks to the 96 tube format of the racks, liquid handling can be easily automated.

AXINON® is very easy to use and requires only a few operator interactions. The system is designed for minimal hands-on time and maximum walk-away time. At full loading of the sample changer, up to 465 samples can be measured without the user having to interact with the test system. Even at full capacity for the AXINON® lipoFIT®-S100 of about 300 samples a day, the operator need only spend 15 minutes interacting with the device and software. Manual pipetting requires approximately 2.5 h for sample preparation.

<i>AXINON<sup>&reg;</sup> lipoFIT<sup>&reg;</sup>-S100</i>

In recent years, there has been increasing evidence that not only the cholesterol itself, but also its "packaging" in lipoprotein particles is critical to the risk of cardiovascular disease. It has been shown, that especially small LDL particles with higher density, so-called small dense LDL (sdLDL), are associated with an increased risk [1]. Thus, a more accurate picture of lipoproteins would help to uncover an otherwise undetected cardiovascular risk and countermeasures could be introduced in good time, e.g. through a change in lifestyle or medication.

After the one-time installation of AXINON® System in which the AXINON® Software and AXINON®lipoFIT®-S100 software are installed on a standard PC and a suitable 600 MHz NMR device is connected, you only need the AXINON® serum kit and NMR tubes from numares for sample preparation. For Urine Samples a Centrifuge capable of 10.000*g for 10 min at room temperature is needed. All measurement data is saved in a local or network instance of a Microsoft SQL Database.

Precision measurements were conducted according to an internal protocol on the basis of guideline CLSI EP5-A2 (1). Reproducibility was assessed at three study sites. Repeatability (within-run imprecision), intermediate precision (between-runs and between-days imprecision) and reproducibility (between-sites imprecision) were determined in serum pools at three concentrations.

If you are interested in an AXINON® System, we will initially send someone to conduct site planning inside your lab. If your lab meets the required specifications and you decide to have an AXINON® System, the technical service department will start planning installation.

That means: ordering the NMR device from the manufacturer, and preparing the installation schedule in conjunction with you and the manufacturer. The time between receipt of the order and delivery of the device can vary but is approximately 6 months. We will keep you updated regularly.

When the device is delivered to your site, it is the manufacturer who will initially be responsible for setting up the magnet. After about 2.5 weeks, the device will be taken over by our service specialist. Within a further 3 weeks the analytical platform as well as the test software will be installed and the system will be completely qualified.

After successful qualification the device including all qualification documents will be handed over to you. In addition, you will receive comprehensive initial and maintenance training to ensure self-confident usage of your new system.

Technical support

Please do not hesitate to contact us via email or via phone at +49 941 280 949-49 (Europe) or +1 833-numares (US). Our technical support team will process your requests during general office hours (working days 9 am until 5 pm both CET (Europe) and EST (USA)).

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